An Observational Study of Pegasys (Peginterferon Alfa-2a) in Patients With HBeAg-Positive or HBeAg-Negative Chronic Hepatitis B
A Multicenter, Prospective, Non-Interventional Study Evaluating Response Parameters During and After Therapy With PEGASYS (Peginterferon Alfa-2a 40KD) in Subjects With HBeAg Positive or HBeAg Negative Chronic Hepatitis B
1 other identifier
observational
50
1 country
2
Brief Summary
This multicenter, prospective, observational study will evaluate the efficacy and safety of Pegasys (peginterferon alfa-2a) in routine clinical practice in patients with HBeAg-positive or HBeAg-negative chronic hepatitis B. Eligible patients receiving treatment with Pegasys according to standard of care and the summary od product characteristics/local labelling will be followed for the duration of treatment and up to 2 years of follow-up.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Aug 2011
Shorter than P25 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedFirst Submitted
Initial submission to the registry
November 21, 2012
CompletedFirst Posted
Study publicly available on registry
November 27, 2012
CompletedNovember 2, 2016
November 1, 2016
1 year
November 21, 2012
November 1, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
Change in HBsAg (IU/ml) levels during therapy (up to 48 weeks) and follow-up
from baseline to up to approximately 3 years
Change in HBV DNA (IU/ml) during therapy (up to 48 weeks) and follow-up
from baseline to up to approximately 3 years
Secondary Outcomes (4)
Percentage of patients with sustained immune control (sustained HBV DNA <2000 IU/ml in HBeAg-negative and HBeAg-positive patients or HBeAg seroconversion in HBeAg-positive patients)
approximately 4 years
Percentage of patients with normalisation of serum alanine transaminase (ALT) levels
approximately 4 years
Percentage of patients with HBsAg clearance/seroconversion
approximately 4 years
Safety: Incidence of adverse events
approximately 4 years
Study Arms (1)
Cohort
Eligibility Criteria
Patients with chronic hepatitis B receiving treatment with Pegasys
You may qualify if:
- Adult patients, \>/= 18 years of age
- HBeAg-positive or HBeAg-negative serologically proven chronic hepatitis B with or without cirrhosis
- Elevated serum ALT \> ULN (upper limit of normal) but \</=10 x ULN according to local label
You may not qualify if:
- Contra-indications to Pegasys as detailed in the label
- Co-infection with hepatitis A, hepatitis B or HIV
- Concomitant therapy with telbivudine (concomitant peginterferon alfa-2a therapy is contra-indicated according to telbivudine label)
- Pregnant or breastfeeding women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Unknown Facility
Berlin, 13353, Germany
Unknown Facility
Leipzig, 04103, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 21, 2012
First Posted
November 27, 2012
Study Start
August 1, 2011
Primary Completion
August 1, 2012
Study Completion
August 1, 2012
Last Updated
November 2, 2016
Record last verified: 2016-11